- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05609786
Dissemination and Implementation of a Web-based Relationship Safety App, myPlanKenya, for Women at Risk for Intimate Partner Violence in Nairobi, Kenya (myPlanKenya)
This effectiveness-implementation hybrid-3 study evaluates dissemination, implementation, and effectiveness of myPlanKenya. myPlanKenya will be disseminated through formal and informal sectors. This clinical trial portion of the study enrolls women at risk for intimate partner violence (IPV) who are referred to myPlanKenya by disseminators (i.e. "end-users").
This trial aims to evaluate the effectiveness of myPlanKenya referral on resilience, health and safety among a cohort of women referred to myPlanKenya based on disclosure of IPV or assessed to have IPV related risks.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nairobi, Kenya
- Ujamaa Africa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female
- Age 16 or older
- Physical or sexual partner violence or relationship-based fears within the past six months; behaviorally assessed
- Living in Nairobi, Kenya with no plans to move in the next 12 months
- Access to a safe smart phone or computer (personal or shared), and comfort using it to access the myPlan Kenya app
- Literate in English or Swahili languages; confirmed by reading and completing a short passage by filling in several blanks with the appropriate words, selected from a drop-down menu.
Exclusion Criteria:
- Male
- Under age 16
- Have not experienced physical or sexual partner violence or relationship-based fears in past 6 months
- Lives outside of the study area or plans to move within the next 12 months
- Does not have access to a safe smart phone or computer, or is uncomfortable using it to access the myPlan Kenya app
- Illiterate in English or Swahili languages
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: myPlan Kenya
myPlan Kenya web-based application
|
The myPlan Kenya app is a web-based safety planning tool that is secure, private, free and personalized to the user.
The app includes multiple, evidence-based modules: Strategies (safety strategies tailored to the user's needs and violence experience); Resources (referrals to local health, safety and justice resources and services); About You (questionnaires that help the user assess their relationship safety and tailor their Strategies, including My Relationship, Red Flags, My Safety, My Priorities); Understanding (knowledge sections that share information on relationships and violence, including Healthy Relationships, Harmful Beliefs About Abuse, About Violence).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in decisional conflict
Time Frame: Baseline, 6-month, 12-month
|
12-item pre-intervention and 10-item post-intervention decisional conflict measures (specific to safety), assessed using a 5-point Likert scale (0-4).
Items are scored from 0-60 pre-intervention and 0-50 post-intervention, with higher scores indicating higher lower decisional conflict and lower scores indicating higher decisional conflict.
|
Baseline, 6-month, 12-month
|
|
Change in resilience as assessed by Connor-Davidson Resilience Scale
Time Frame: Baseline, 6-month, 12-month
|
10-item Connor-Davidson Resilience Scale, which assesses resilience using a 5-point Likert scale (0-4).
Items are scored from 0-40, with higher scores indicating greater resilience and lower scores indicating lower resilience.
|
Baseline, 6-month, 12-month
|
|
Change in safety/IPV experience(s) as assessed by the Conflict Tactics Scale-2
Time Frame: Baseline, 6-month, 12-month
|
10-item adapted Conflict Tactics Scale-2 (CTS2), which assesses IPV experiences using a 3-point scale on the frequency of these experiences.
|
Baseline, 6-month, 12-month
|
|
Change in help-seeking
Time Frame: Baseline, 6-month, 12-month
|
6-item index on help-seeking, which assesses abuse disclosure and services/information received on a 2-point scale (yes/no), and the helpfulness of these disclosures and services on a 5-point Likert scale.
Scale examined for fit and will be handled as individual items as needed.
|
Baseline, 6-month, 12-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in safety strategies
Time Frame: Baseline, 6-month, 12-month
|
5-item index on safety strategies, which assesses the use of strategies on a 2-point scale (yes/no), and the helpfulness of these strategies on a 5-point Likert scale.
|
Baseline, 6-month, 12-month
|
|
Change in IPV recognition as assessed by the Abusive Behaviors Scale
Time Frame: Baseline, 6-month, 12-month
|
7-item adapted Abusive Behaviors Scale, which assesses IPV recognition using a 5-point Likert scale (0-4).
Items are scored from 0-35, with higher scores indicating greater IPV recognition and lower scores indicating lower IPV recognition.
|
Baseline, 6-month, 12-month
|
|
Change in relationship intention
Time Frame: Baseline, 6-month, 12-month
|
Single item which assesses intention for current relationship on a 4-point scale.
|
Baseline, 6-month, 12-month
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michele Decker, Johns Hopkins Bloomberg School of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00017456
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Violence, Domestic
-
University of the Virgin IslandsUnknownDomestic Violence | Domestic AbuseVirgin Islands (U.S.)
-
Medical Research Council, South AfricaUniversity of GhanaUnknownSexual Violence | Domestic Violence | Physical ViolenceGhana
-
Johns Hopkins UniversityUniversity of Pittsburgh; Office of Research on Women's Health (ORWH); Futures...CompletedViolence, Domestic | Violence, SexualUnited States
-
Funmilola OlaOlorunUniversity of IbadanCompletedDomestic Violence | Violence | AttitudeNigeria
-
Karolinska InstitutetRegion Stockholm; Jane and Dan Olsson Foundation for Scientific PurposesCompletedDomestic Violence | Family Violence | Intimate-partner ViolenceSweden
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedDomestic Violence | Intimate Partner ViolenceUnited States
-
NMP Medical Research InstituteWarwick Research Services; Arsha Vidya Study Centre, Tamilnadu, IndiaCompletedDomestic Violence | Intimate Partner ViolenceIndia
-
University of PittsburghCompletedViolence in Adolescence | Domestic ViolenceUnited States
-
University of SheffieldUniversity of HuddersfieldCompleted
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedViolence, Domestic | Violence-Related SymptomUnited States
Clinical Trials on Personalized safety planning tool
-
Johns Hopkins UniversityUniversity of Missouri-Columbia; Centers for Disease Control and PreventionCompletedIntimate Partner ViolenceUnited States
-
Henry M. Jackson Foundation for the Advancement...University of Pennsylvania; Columbia University; United States Department of... and other collaboratorsCompletedSuicide, Attempted | SuicideUnited States
-
Rhode Island HospitalNational Institute of Mental Health (NIMH)UnknownImplementing a Brief Suicide Intervention for High Risk Youth With Front-Line Juvenile Justice StaffSuicide and Self HarmUnited States
-
University of British ColumbiaCanadian Foundation for Women's HealthWithdrawn
-
Central FITT, IncUnknown
-
San Diego State UniversityNational Institute of Mental Health (NIMH)Active, not recruitingSuicideUnited States
-
Brown UniversityNational Institute of Mental Health (NIMH); The Miriam HospitalCompletedSuicidal Ideation | Suicide, Attempted | Nonsuicidal Self-injuryUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedViolence, Domestic | Violence-Related SymptomUnited States
-
Region SkaneForteRecruitingSuicide AttemptSweden
-
University of ArkansasCompletedSuicidal Ideation | Suicide, Attempted | Mental Health IssueUnited States